Roche's Gazyva shows promise in Lupus nephritis trial

Roche’s Gazyva is already approved in leukaemia and lymphoma – but could it work in the autoimmune kidney disease Lupus nephritis too?

Gazyva (obinutuzumab) works by targeting CD-20, a protein only found in B-cells that cause leukaemia and lymphoma, and become abnormally stimulated in patients with Lupus.

Lupus nephritis is a complication of systemic lupus erythematosus (SLE), an autoimmune disease where a person's own immune system attacks healthy cells and organs.

In the US, 1.5 million people are affected by lupus, with around 70% of cases developing systemic lupus erythematosus (SLE).

Around 60% of SLE patients develop lupus nephritis, and a quarter of those develop end-stage renal disease.

Latest data from Roche’s Genentech unit show the phase 2 NOBILITY study met its endpoint in combination with standard of care, outperforming a control group treated with only standard medicines plus placebo.

These are mycophenolate mofetil or mycophenolic acid and corticosteroids.

Genentech does not disclose detailed results but said the Gazyva combination met the trial’s primary endpoint by outperforming standard of care at achieving complete renal response at one year.

Gazyva met key secondary endpoints showing improved overall renal responses (complete and partial renal response) and serologic markers of disease activity as compared to placebo.

The study enrolled 126 people who were randomized to receive Gazyva or placebo infusions on Days 1, 15, 168, and 182.

Sandra Horning, chief medical officer at Roche, said: “There are no FDA-approved treatments for lupus nephritis, a potentially life-threatening condition in which patients are at high risk of progressing to end-stage renal disease or death.

“We have been investigating a possible treatment for lupus nephritis for more than a decade and have integrated key learnings from that experience in how we study the condition.

“We are encouraged by the NOBILITY results, which showed a statistically significant difference in achievement of complete renal response, overall renal response, and other measures of disease activity and support the potential for a new treatment option for people living with lupus nephritis.”